Package Insert: Information for the Patient

Inacid 25 mg Hard Capsules

Indometacin

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Inacid contains indometacin as the active ingredient, which belongs to a class of medications known as non-steroidal anti-inflammatory and anti-rheumatic drugs.

Inacid is indicated for symptomatic treatment in patients who suffer from:

• Rheumatoid arthritis, ankylosing spondylitis (inflammation affecting the joints of the spine) and osteoarthritis.
• Acute gout attack.
• Acute musculoskeletal processes.
• Post-traumatic inflammation, pain, and swelling.

Do not take Inacid:

• if you are allergic to indomethacin or any of the other components of this medication (listed in section 6),
• if you have had asthma, rhinitis, urticaria, or other allergic reactions to nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin,
• if you have a history of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs,
• if you have active or recurrent peptic ulcer/gastrointestinal bleeding,
• if you have a serious heart condition,
• if you are in the third trimester of pregnancy or breastfeeding your child,
• if you are undergoing postoperative pain treatment in the case of coronary artery bypass grafting (CABG), heart surgery to treat a blocked coronary artery,
• if you are under 14 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting this medication.

You should avoid taking Inacid with other NSAIDs, including other anti-inflammatory medications such as selective COX-2 inhibitors.

Inform your doctor if you experience or have experienced any of the following conditions:

• Gastrointestinal bleeding, ulcers, or perforations in the stomach or intestine.
• Hypertension, heart problems, or have had a stroke.
• Severe skin alterations.
• Any serious liver disease or abnormal liver function tests.
• Renal insufficiency.
• Bleeding or other coagulation problems.
• Psychiatric disorders, epilepsy, or Parkinson's disease.
• Infections.
• Blood disorders, such as decreased white blood cells, red blood cells, or platelets.
• Allergy to lactose or any other component of Inacid 25 mg capsules.

Inform your doctor

• If you are taking medications that alter blood coagulation, such as corticosteroids, oral anticoagulants, or antiplatelet agents like aspirin. You should also inform your doctor about the use of other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
• If you have Crohn's disease or ulcerative colitis, as indomethacin-type medications may worsen these conditions. If you experience abdominal pain, diarrhea, or vomiting, stop taking Inacid and inform your doctor immediately.

Gastrointestinal risks:

The most common adverse effects that occur with medications like Inacid are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in older adults. Less frequently, gastritis has been observed. These may occur at any time during treatment with or without prior warning.

The risk of gastrointestinal bleeding is higher when using high doses, if you have a history of peptic ulcers, or are an older adult. In these cases, your doctor may consider associating a stomach protector.

If you experience abdominal pain, vomiting blood, or material with a coffee ground appearance or black stools, these may be symptoms of gastrointestinal bleeding. Stop taking Inacid and seek medical help immediately.

CARDIOVASCULAR RISKS:

Medications like Inacid may be associated with a moderate increase in the risk of having a heart attack (myocardial infarction) or stroke.This risk is more likely to occur when using high doses and prolonged treatment. Your doctor may monitor your blood pressure as Inacid may cause it to increase.

It is essential to take the lowest dose of Inacid that alleviates/controls your symptoms for the shortest time possible.

If you have heart problems, have had a heart attack, a history of strokes, or think you may be at risk for these conditions (e.g., have high blood pressure, diabetes, high cholesterol, or are a smoker), you should consult this treatment with your doctor.

RISK OF SEVERE SKIN REACTIONS:

Medications like Inacid may be associated, in very rare cases, with severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

The highest risk of experiencing these reactions is at the beginning of treatment (usually within the first month of treatment). If you experience skin eruptions, possibly with the formation of blisters or mucosal ulcers (e.g., in the mouth), or other symptoms of an allergic reaction, stop taking Inacid and consult your doctor immediately.

RISK OF LIVER REACTIONS:

Medications like Inacid may be associated with liver disorders that cause yellowing of the skin and eyes, sometimes with elevated fever or swelling and sensitivity in the upper abdomen.

Vision:

If you experience blurred vision while taking Inacid, stop taking Inacid and inform your doctor.

Other precautions:

Inform your doctor if you experience headaches, possibly with dizziness and drowsiness after taking Inacid.

In some cases, Inacid may worsen psychiatric disorders, epilepsy, and Parkinson's disease. Therefore, if you suffer from any of these conditions and notice a worsening, you should consult this treatment with your doctor.

Like other NSAIDs, Inacid may mask the symptoms of an infection.

Your doctor may instruct you to undergo blood tests during treatment with Inacid to monitor your blood cells, liver function, renal function, or blood levels of other medications.

Children and adolescents:

Do not administer to children under 14 years old.

Use of Inacid with other medications:

Inform your doctor or pharmacist if you are taking or have taken recently, or may need to take any other medication.

Certain medications may interact with Inacid. In these cases, it may be necessary to change the dose or discontinue treatment with one of the other medications.

This is especially important if you are taking:

• Anticoagulants, antiplatelet agents (to prevent blood coagulation).
• Corticosteroids (e.g., cortisone, prednisone) (used to treat various types of inflammation or autoimmune diseases).
• Selective serotonin reuptake inhibitors (SSRIs) (used to treat depression).
• Aspirin or other NSAIDs, including selective COX-2 inhibitors, and diflunisal (used to treat fever, pain, or inflammation).
• Probenecid (used to treat gout).
• Methotrexate (used to treat certain types of cancer, psoriasis, or rheumatic diseases).
• Ciclosporin (used to suppress the immune system).
• Lithium (used to treat a certain type of depression).
• Diuretics, angiotensin receptor antagonists, angiotensin-converting enzyme inhibitors (ACE inhibitors), and renin-angiotensin system inhibitors (used to treat high blood pressure).
• Digoxin (used to treat heart diseases).
• Phenylpropanolamine (appetite suppressant).

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

Do not take Inacid if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your tendency and that of your baby to bleed and delay or prolong delivery more than expected. Do not take Inacid during the first 6 months of pregnancy unless it is clearly necessary and as directed by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest time possible. If you take it for more than a few days after week 20 of pregnancy, Inacid may cause kidney problems in your fetus, which may cause low amniotic fluid levels (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional monitoring.

Due to the association of administering medications like Inacid with a higher risk of congenital anomalies/abortions, its administration is not recommended during the first and second trimesters of pregnancy, except in cases where it is strictly necessary. In these cases, the dose and duration of treatment will be limited to the minimum possible.

Breastfeeding:

Indomethacin is secreted in breast milk, so you should not take this medication if you are breastfeeding.

Fertility:

Inacid may decrease your ability to conceive. Inform your doctor if you are planning to become pregnant or if you have any difficulty becoming pregnant.

Driving and operating machinery:

Inacid may cause drowsiness, dizziness, and blurred vision. In these cases, do not drive or operate any hazardous tools or machinery that require being alert.

Inacid contains lactose:

This medication contains lactose. If you have an intolerance to certain sugars, consult your doctor before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will indicate the dose you should take and the duration of treatment. It is important to use the lowest dose that controls your pain and do not take Inacid for longer than necessary to control symptoms.

Recommended dose is:

Adults

The usual dose is 50 mg to 200 mg of indomethacin per day, administered in divided doses.

Rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis:25 mg of indomethacin (1 capsule) every 8-12 hours. If necessary, your doctor may increase the dose progressively in doses of 25 mg or 50 mg up to a maximum of 200 mg of indomethacin per day.

Acute gout attack:50 mg of indomethacin (2 capsules) every 8 hours, up to a maximum of 200 mg per day and until the disappearance of symptoms. It should only be used during the period of acute pain.

Musculoskeletal processes, muscle pain, and inflammation:25 mg of indomethacin (1 capsule) every 6 or 8 hours, until symptoms disappear (1-2 weeks).

Maximum daily dose

Do not take more than 200 mg of indomethacin per day.

Older adults

Your doctor may prescribe a lower daily dose and reduce the duration of treatment.

Use in children and adolescents

Inacid should not be used in children under 14 years old.

Patients with kidney problems

If you have any kidney disease, consult your doctor before taking this medication.

Administration form:

Oral.

The capsules should be swallowed whole with or after a meal, and with sufficient amount of water or other liquid to reduce the risk of stomach discomfort.

If you take more Inacid than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, Phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Inacid

Do not take a double dose to compensate for the missed dose.

If you have any other doubt about the use of this medication, ask your doctor or pharmacist.

If you interrupt the treatment with Inacid

If you have any doubt about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience any of these side effects, stop taking this medicine and see a doctor.

• Severe allergic reaction, such as swelling of the face, lips, or throat, wheezing or difficulty breathing, sudden drop in blood pressure, skin rashes.
• Severe abdominal pain (stomach pain) or other abdominal symptoms.
• Blood in stool.
• Black stools.
• Vomiting blood or dark material that looks like coffee grounds.
• Jaundice (yellowing of the skin and the white part of the eyes).
• Blisters or peeling of the skin.
• Irregular red patches on the skin of the hands and arms.

The following side effects have been reported:

Very common (may affect more than 1 in 10 people).

Headache, dizziness, drowsiness, vertigo.

Common (may affect up to 1 in 10 people).

Depression, fatigue or tiredness, nausea, loss of appetite, vomiting, indigestion, stomach pain, constipation, diarrhea.

Uncommon (may affect up to 1 in 100 people).

Ringing in the ears, hearing disorders, liver enzyme test abnormalities, abdominal pain, intestinal bleeding or perforation, mouth inflammation, stomach irritation, flatulence, fluid retention, hair loss.

Rare (may affect up to 1 in 1,000 people).

Itching skin, urticaria, blood vessel inflammation, skin rash, sudden difficulty breathing, asthma, fluid in the lungs, psychological disorders, delirium, confusion, anxiety, fainting, drowsiness, numbness or tingling in the extremities, speech problems, insomnia, worsening of epilepsy or Parkinson's disease, involuntary muscle movements, muscle weakness, seizures, coma, blurred vision, double vision, eye pain, hearing loss, rapid heart rate, irregular heartbeat, heart failure, chest pain, high blood pressure, low blood pressure, hepatitis, liver disorders, ulcers in the esophagus, stomach, and small or large intestine, blood in urine, vaginal bleeding, breast enlargement (also in men), breast tenderness, redness, sweating, nasal bleeding, high potassium or glucose levels in the blood, glucose in urine, high urea levels in the blood.

Very rare (may affect up to 1 in 10,000 people).

Decreased white blood cells, deficiency of a type of white blood cells, deficiency of red blood cells, decreased platelets, skin hemorrhages, coagulation disorders, deposits in the cornea of the eye, retinal abnormalities, abnormal protein levels in urine, kidney disorders, kidney failure.

Unknown frequency (cannot be estimated from available data).

Pancreatitis inflammation.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

No special storage conditions are required.

Composition of Inacid 25 mg

• The active ingredient is indometacin. Each capsule contains 25 mg of indometacin.
• The other components (excipients) are: lactose monohydrate, lecithin, magnesium stearate, anhydrous colloidal silica, gelatin, titanium dioxide (E171) and iron oxide yellow (E172).

Appearance of the product and contents of the packaging

The capsules are hard gelatin capsules of a light ivory color.

Inacid 25 mg capsules are packaged in PVC/aluminum blisters, presented in cardboard containers that contain 20 or 50 hard capsules.

Holder of the Marketing Authorization and Responsible for Manufacturing

Holder of the Marketing Authorization

H.A.C. PHARMA

Péricentre II-

43, Avenue de la Côte de Nacre

14000 CAEN

France

Responsible for Manufacturing

allphamed Pharbil Arzneimittel GmbH

Hildebrandstrasse 10-12

37081 Göttingen, Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Euromed Pharma Spain, S.L.C/Eduard Maristany, 430-432

08918 Badalona

Barcelona - Spain

Tel: + 34 932 684 208

Fax: + 34 933 150 469

Last review date of this leaflet:December 2022

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es